Comparing Effects of Conventional Neurorehabilitation with Exoskeleton with High-intensity Gait Training

Last updated: October 3, 2024
Sponsor: Alvernia University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Stroke

Cerebral Ischemia

Treatment

High intensity gait training

Exoskeleton mediated gait training

Clinical Study ID

NCT06478680
2176775-1
  • Ages > 18
  • All Genders

Study Summary

The purpose of this research is to compare improvements between the rehab intervention with walking practice using the robotic exoskeleton versus walking practice that is vigorous enough to keep participants' heart rate over a certain target level during physical therapy sessions. Investigators want to compare improvements in your walking function and mental health that occur after 20 interventions. The study also aims to evaluate if participants' mental health, social support, and health literacy affect attendance at physical therapy sessions.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 18 years of age or older

  • English or Spanish-speaking

  • A diagnosis of stroke (intracerebral hemorrhage or acute ischemic stroke)

  • Referred to Good Shepherd Rehabilitation Outpatient Physical Therapy Clinic

Exclusion

Exclusion Criteria:

  • Unable to follow 1-step commands

  • > 220 pounds (100 kg)

  • Height < 5'0" or > 6'4"

  • Unable to take a few steps with assistance

  • A score of ≥ 50/56 on Berg Balance Scale (BBS)

  • A score of ≥ 26/30 on Functional Gait Assessment (FGA)

  • Resting blood pressure >180/110 mmHg

  • Resting heart rate > 120 bpm

  • Severe cardiac disease (New York Heart Association Classification IV)

  • Severe spasticity (Modified Ashworth score > 3)

  • Unstable spine or unhealed pelvic/limb fractures

  • Active heterotrophic ossification impacting lower extremity range of motion

  • Significant lower or upper extremity contractures

  • Inability to achieve neutral ankle dorsiflexion with 12° of knee flexion

  • Pregnancy

  • Colostomy

  • Poor skin integrity in areas in contact with the EksoGTTM

  • Unresolved deep vein thrombosis

  • Lower limb prosthesis or amputation

  • Leg length discrepancies > 0.5 inches for upper legs, 0.75 inches for lower legs

  • ROM restrictions preventing normal, reciprocal gait

  • Inability to stand for > 3 minutes due to pain or orthostatic hypotension

  • Pusher syndrome

  • Cortical blindness

Study Design

Total Participants: 62
Treatment Group(s): 2
Primary Treatment: High intensity gait training
Phase:
Study Start date:
October 01, 2024
Estimated Completion Date:
December 30, 2025

Connect with a study center

  • Good Shepherd Rehabilitation

    Allentown, Pennsylvania 18103
    United States

    Active - Recruiting

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